Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Depression Clinical Trial

Official title:

Face-to-face CBT Treatment of Depression With Smartphone Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819025
• Other study ID #: GA-PC-HH-KHL
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: February 6, 2014
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2013
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

Description:

Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades.

Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions.

Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• depressive symptoms according to DSM-IV

• have access to a smartphone and to the Internet

• have good knowledge of the Swedish language

Exclusion Criteria:

• recent (during last 6 weeks) change in psychiatric medication

• presently in any other psychological treatment

• severe depression

• suicidal ideation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 4 face-to-face therapy session and a smartphone-app
An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.
• CBT, treatment as usual
10 sessions of face-to-face therapy, full behavioral activation

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)- Change from baseline	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	Yes
Primary	Beck Depression Inventory (BDI)- Change from baseline	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	Quality of Life Inventory (QOLI)- Change from baseline	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	Acceptance & Action Questionnaire (AAQ)- Change from baseline	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	Beck Anxiety Inventory (BAI)- Change from baseline	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline	Change from baseline in health cost burden and at six months post treatment.	Two weeks pre treatment and at six months post treatment.	No